Genentech Moves Up Timeline of Avastin Trial on Cancer


Genentech said on Thursday a trial of Avastin in colon cancer patients who have undergone surgery will be completed earlier than expected due to faster collection of data and a higher-than-planned number of patients with stage III cancer.

Final results from the trial, which is being conducted by the National Surgical Adjuvant Breast and Bowel Project, are expected next year, rather than in 2010, the company said.

Genentech said the update does not change its assessment of the Phase III study's probability of success.

The trial involves more than 2,700 patients with stage II and III cancer.

The company also said the last interim independent assessment of the study took place in the second quarter of this year and found no new or unexpected safety events.

Genentech said the incidence of non-cancer-related deaths was similar between the treatment arms and consistent with prior Phase III adjuvant colon cancer trials.

No significant increases in gastrointestinal perforation, hemorrhage, arterial or venous thrombotic events or deaths were observed in the Avastin part of the trial.

The safety results will be presented at the May 30 to June 3 annual meeting of the American Society of Clinical Oncology.

At the time of abstract submission, analysis showed that severe side effects that occurred more often in the Avastin plus chemotherapy part of the trial included hypertension (12.7 percent versus 1.8 percent), wound healing complications (1.7 percent versus 0.3 percent) and pain (6.9 percent versus 3.4 percent).

"Due to the high cure rate for early-stage colon cancer, there is a lower acceptance of risk related to potential new therapies in the adjuvant treatment setting," said Dr.David Schenkein, Genentech's senior vice president, clinical hematology and oncology.